CDRH launches a pilot of its new eSTAR platform for 510(k) submissions.
FDA releases the FDA-483 with four observations from an inspection at Dynalabs.
Two months ahead of its user fee review goal, FDA approves Puma Biotechnologys Nerlynx (neratinib) in combination with capecitabine for certain adult ...
FDA commissioner Stephen Hahn says FDA is using the best available science to evaluate possible non-drug regulatory pathways for CBD products.
Vizient says a consequence of FDA approval of four drugs under its Unapproved Drugs Initiative is an increase in health system spending of more than $...
Y-mAbs Therapeutics says it will complete in 10 weeks a rolling BLA for omburtamab for treating patients with central nervous system/leptomeningeal me...
FDA grants Takeda Pharmaceutical Co. a priority review for its supplemental NDA that seeks to expand the use of Alunbrig (brigatinib) as a first-line ...
Three industry stakeholders recommend that FDA add information to a draft guidance on pediatric studies of molecularly targeted oncology drugs.